MEA Regulatory Affairs Sr Associate

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen , our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Job purpose:

As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.

Job Responsibilities:

Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics

Manage Performance Excellence through collection, analyzing & disseminating relevant information to team(s) as appropriate

Participate in local regulatory process improvements initiatives

Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics

Ensure delivery of right first time label source text for artwork creation

Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner

Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region

Access the translation agency systems to request the label translation and track the job readiness and timelines.

Perform regional prescribing information translation review: 100% review of both content and format

Perform the role of source text owner/approver and artwork reviewer/approver in the system

Trigger the existing label revision when alerted by global RA team.

Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)

Collate, distribute and exchange regulatory information with other re